Pi-Cardia ShortCut Transfemoral Catheter Recalled for Detachment Risk
Pi-Cardia is recalling 46 ShortCut transfemoral catheters because the positioning arm may detach due to a weld issue.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (detachment) in a medical device, which meets the criteria for a Severe rating.
Plain-English summary
Pi-Cardia Ltd is recalling 46 units of the ShortCut transfemoral catheter (REF: Z-A-20.003-US). The recall is due to a weld issue that may cause the positioning arm to detach.
The affected units were distributed nationwide in Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York. The specific serial numbers affected are listed in the recall documentation under lot SCUS-00013.
Healthcare providers should stop using the affected devices and contact Pi-Cardia for instructions on return or replacement.
The recalled product
- Product
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Manufacturer
- PI CARDIA LTD
- Category
- Medical Device — Catheter
- Affected units
- 46
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 (20)
- SC920
- SC921
- SC923
- SC924
- SC925
- SC926
- SC927
- SC928
- SC929
- SC930
- SC931
- SC932
- SC933
- SC934
- SC935
- SC936
- SC937
- SC938
- SC939
- SC940
Distribution
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