Hemostasis valves recalled because deformed quad rings may shed foreign bodies
10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a foreign body in the fluid pathway is a potential harm and no injuries are reported.
Plain-English summary
The 10Fore Hemostasis Valve, catalog numbers MAPTEN4, MAPTEN42 and MAPTEN452 with UDI-DI codes 00884450821305, 00884450832509 and 00884450821329, is being recalled. Affected lot numbers include H3098831, H3111155, H3152503, H3155611 and H31869, with the full list in the recall notice. The valve is intended to maintain hemostasis during the introduction, withdrawal and use of devices. The recall covers 447 units distributed in California, Florida, Louisiana, Montana, New York, South Dakota and Wisconsin, and internationally.
The recall follows a manufacturing issue involving the silicone quad ring, where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. The FDA classified the action as Class II.
Hospitals holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 447
Distribution
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