CODMAN® · recalls, adverse events, clearances

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.

5 linked reportsMalfunction 5

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	2
2019-10	0	22
2021-04	0	2
2021-07	0	1
2021-09	1	1
2022-03	0	1
2022-09	1	1
2023-07	0	1
2023-12	0	5
2024-02	0	2
2025-02	1	1
2025-05	2	2

This device (reports/month)Average device in HBO (reports/device/month)

Failure-mode summaryAI-generated

5 linked report narratives available — no AI summary generated yet.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2021-06-01	Z-2224-2021	Class II	Terminated	Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrierDistribution: US Nationwide Distribution - Foreign Distribution: Hong Kong	906 units	code info di

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-05-28	3014334038-2025-00070	Malfunction	Available	exact di
2025-05-13	3014334038-2025-00062	Malfunction	Available	exact di
2025-02-05	3014334038-2025-00014	Malfunction	Available	exact di
2022-09-13	3014334038-2022-00202	Malfunction	Available	exact di
2021-09-22	3014334038-2021-00196	Malfunction	Available	exact di

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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