Boston Scientific ROTAPRO System Console Recalled for Manufacturing Instruction Deficiency
Boston Scientific recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.
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: FDA Class II recall of a cardiovascular medical device. The incomplete manufacturing instructions regarding pneumatic component testing create a risk of device malfunction during critical medical procedures. No injuries have been reported.
Plain-English summary
Boston Scientific Corporation is recalling 7 units of the ROTAPRO Rotational Atherectomy System Console (US model H74939309010, EU model H74939309030). The recall addresses an internal manufacturing nonconformity: the manufacturing instructions did not include proper directions specifying that the pneumatic kit component should not be retested upon failure.
The affected devices were distributed in the US states of Florida, Nevada, New York, Ohio, Pennsylvania, and Washington, as well as Germany. The recalled US serial numbers are RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040. The recalled EU serial number is RP005010.
This device recall is classified as FDA Class II.
The recalled product
- Product
- Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- US Serial numbers RP005005
- RP005013
- RP005017
- RP005036
- RP005039
- and RP005040
- GTIN 08714729975076
- EU Serial number RP005010
- GTIN 08714729975151.
Distribution
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