Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionVAPROX0724995MMVAPROXHCSTRL6L
Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
9 linked reportsMalfunction 9
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3 |
| 2019-02 | 0 | 2.83 |
| 2019-03 | 0 | 3 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.4 |
| 2019-06 | 0 | 1.4 |
| 2019-07 | 0 | 3.67 |
| 2019-08 | 0 | 3 |
| 2019-09 | 0 | 2.4 |
| 2019-10 | 0 | 3.8 |
| 2019-11 | 0 | 3 |
| 2019-12 | 0 | 4.33 |
| 2020-01 | 0 | 2.17 |
| 2020-02 | 0 | 4 |
| 2020-03 | 0 | 1.71 |
| 2020-04 | 0 | 3.14 |
| 2020-05 | 0 | 1.8 |
| 2020-06 | 0 | 3 |
| 2020-07 | 0 | 2.29 |
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 2.5 |
| 2020-10 | 0 | 2.33 |
| 2020-11 | 0 | 2.5 |
| 2020-12 | 0 | 1.6 |
| 2021-01 | 0 | 2.33 |
| 2021-02 | 0 | 3.5 |
| 2021-03 | 0 | 2.43 |
| 2021-04 | 0 | 4.5 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 2.83 |
| 2021-08 | 0 | 2.08 |
| 2021-09 | 0 | 2.8 |
| 2021-10 | 0 | 2.13 |
| 2021-11 | 0 | 2.13 |
| 2021-12 | 0 | 2.57 |
| 2022-01 | 0 | 2.5 |
| 2022-02 | 0 | 1.17 |
| 2022-03 | 0 | 3 |
| 2022-04 | 0 | 2.4 |
| 2022-05 | 0 | 2.88 |
| 2022-06 | 0 | 1.83 |
| 2022-07 | 0 | 2.67 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.86 |
| 2022-10 | 0 | 1.63 |
| 2022-11 | 0 | 1.88 |
| 2022-12 | 0 | 3.17 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1.73 |
| 2023-03 | 0 | 1.78 |
| 2023-04 | 0 | 2.5 |
| 2023-05 | 0 | 2.8 |
| 2023-06 | 0 | 1.92 |
| 2023-07 | 0 | 2.3 |
| 2023-08 | 0 | 2.4 |
| 2023-09 | 0 | 1.56 |
| 2023-11 | 0 | 1.5 |
| 2023-12 | 0 | 2.75 |
| 2024-01 | 0 | 1.33 |
| 2024-03 | 1 | 1.25 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1.5 |
| 2024-06 | 0 | 2 |
| 2024-08 | 0 | 3.67 |
| 2024-09 | 0 | 4.75 |
| 2024-10 | 0 | 2.5 |
| 2024-11 | 0 | 1.7 |
| 2024-12 | 2 | 1.25 |
| 2025-01 | 2 | 1.6 |
| 2025-02 | 0 | 1.67 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 2.75 |
| 2025-05 | 0 | 1.75 |
| 2025-06 | 2 | 4.6 |
| 2025-07 | 0 | 5 |
| 2025-08 | 0 | 3.33 |
| 2025-09 | 0 | 2.67 |
| 2025-10 | 0 | 2.33 |
| 2025-11 | 0 | 3 |
| 2025-12 | 2 | 1.71 |
| 2026-01 | 0 | 3.4 |
| 2026-02 | 0 | 5 |
| 2026-03 | 0 | 2.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 2.8 |
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2018-07-26 | Z-2959-2018 | Class II | Terminated | There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.Distribution: Worldwide Distribution: US(nationwide) and to countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Belarus, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Suriname, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam. | 2889 units | clearance family |
| 2017-09-28 | Z-0772-2018 | Class II | Terminated | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.Distribution: Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Republic of Korea, Kuwait, Latvia, Malaysia, Mexico, Morocco, Myanmar, Panama, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and Vietnam. | 406 | clearance family |
| 2011-08-01 | Z-3041-2011 | Terminated | STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device's chamber following a failed leak test. | — | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-17 | 3003950207-2025-00012 | Malfunction | Available | catalog number |
| 2025-06-12 | 3003950207-2025-00007 | Malfunction | Available | catalog number |
| 2025-01-02 | 3003950207-2025-00001 | Malfunction | Available | catalog number |
| 2024-12-31 | 3003950207-2024-00011 | Malfunction | Available | catalog number |
| 2024-03-28 | 3003950207-2024-00003 | Malfunction | Available | exact di |
Showing the most recent 5 of 9 linked reports.
Regulatory clearances
- 510(k)K233065Substantially equivalent (SESE) · 2023-10-20clearance family
- 510(k)K223476Substantially equivalent (SESE) · 2023-08-07clearance family
- 510(k)K222093Substantially equivalent (SESE) · 2022-09-09clearance family
- 510(k)K190917Substantially equivalent (SESE) · 2019-05-09clearance family
- 510(k)K190103Substantially equivalent (SESE) · 2019-04-05clearance family
- 510(k)K182568Substantially equivalent (SESE) · 2019-01-03clearance family
- 510(k)K172754Substantially equivalent (SESE) · 2018-02-09clearance family
- 510(k)K172319Substantially equivalent (SESE) · 2018-01-18clearance family
- 510(k)K162413Substantially equivalent (SESE) · 2017-03-31clearance family
- 510(k)K160433Substantially equivalent (SESE) · 2016-07-06clearance family
- 510(k)K140498Substantially equivalent (SESE) · 2014-07-24clearance family
- 510(k)K131120Substantially equivalent (SESE) · 2013-07-16clearance family
- 510(k)K120632Substantially equivalent (SESE) · 2012-06-26clearance family
- 510(k)K112813Substantially equivalent (SESE) · 2011-12-01clearance family
- 510(k)K112760Substantially equivalent (SESE) · 2011-11-22clearance family
- 510(k)K111810Substantially equivalent (SESE) · 2011-09-02clearance family
- 510(k)K102394Substantially equivalent (SESE) · 2011-08-18clearance family
- 510(k)K102330Substantially equivalent (SESE) · 2011-08-12clearance family
Predicate lineage
K062297
Cited as predicate by: K102330, K102394, K103226, K111810, K112760, K112813, K120632, K131120, K162413, K172319, K231893, K233065
K083097
Cited as predicate by: K102330, K102394, K103226, K111810, K112760, K112813, K120632, K131120, K140464, K140498, K140499, K160433, K162413, K172319, K231893
Cited as predicate by: K103226, K112760, K112813, K120632, K131120, K140498, K140499, K160433, K162413, K172319, K172749, K172754, K172755, K211895, K231893
- K131120
Cited as predicate by: K140498, K141163, K160433, K162413, K172319, K172749, K172754, K172755
- K140498
- K160433
- K162413
- K172319
- K172754
Cited as predicate by: K172755
- K182568
- K190917
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-04-16 | NAI | No action indicated | Steris Corporation | 0 |
| 2026-04-16 | NAI | No action indicated | Steris Corporation | 0 |
| 2026-04-03 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2026-03-12 | NAI | No action indicated | Isomedix Operations Inc | 0 |
| 2026-02-26 | VAI | Voluntary action indicated | Steris S.p.A. | 1 |
| 2026-02-12 | VAI | Voluntary action indicated | Synergy Health Ede BV | 2 |
| 2026-02-12 | NAI | No action indicated | Synergy Health Marseille | 0 |
| 2025-12-12 | OAI | Official action indicated | Black Diamond Video Inc. | 3 |
| 2025-08-01 | VAI | Voluntary action indicated | STERIS Laboratories, Inc. | 2 |
| 2025-06-18 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2025-06-17 | NAI | No action indicated | Isomedix Operations Inc | 0 |
| 2025-06-05 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2025-04-01 | NAI | No action indicated | Steris Corporation | 0 |
| 2025-02-21 | NAI | No action indicated | Isomedix Operations Inc. | 0 |
| 2025-01-23 | NAI | No action indicated | Synergy Health Allershausen GmbH | 0 |
| 2024-12-12 | VAI | Voluntary action indicated | Isomedix Operations, Inc | 0 |
| 2024-12-05 | NAI | No action indicated | Steris (Synergy Health Ede BV) | 0 |
| 2024-11-21 | VAI | Voluntary action indicated | Steris Applied Sterilization Technologies ULC | 2 |
| 2024-09-23 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2024-09-19 | NAI | No action indicated | Isomedix Operations, Inc. | 0 |
| 2015-02-20 | WL | Warning Letter | Key Surgical LLC | — |
| 2014-05-22 | WL | Warning Letter | Isomedix Operations, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Albert Browne Ltd. | — |
| 2011-02-09 | WL | Warning Letter | Steris Corporation | — |
| 2011-02-09 | WL | Warning Letter | Steris Corporation | — |
| 2010-09-27 | WL | Warning Letter | Isomedix Operations, Inc. | — |
| 2010-04-20 | INJ | Injunction | Steris Corporation | — |
| 2010-04-20 | INJ | Injunction | Steris Corporation | — |
| 2009-07-31 | WL | Warning Letter | Medivators Inc | — |
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