Abiomed Introducer Set Recall Due to Sidearm Detachment Risk
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
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 medical device with documented manufacturing defect causing potential structural failure (sidearm detachment). One device failure confirmed but no injuries reported. Scores 3 (High) per rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
The Abiomed 14Fr Low Profile Introducer Set (Product Number 1000457) is being recalled due to a manufacturing defect that may cause the device's sidearm to detach. Abiomed, Inc. identified one complaint in which the sidearm detached during pump removal. The defect stems from unintentional silicone oil contamination introduced during manufacturing at the joint between the sidearm and the hub.
When the sidearm is exposed to heat, humidity, and repeated bending during clinical use, the silicone oil contaminant may weaken the joint and cause it to detach.
Affected units include 37 devices distributed nationwide in Minnesota, New Jersey, and Tennessee. The recalled lot numbers are 1727033 and 1725590, with UDI-DI 00813502013252. Although one device failure has been documented, no patient injuries have been reported to date.
Healthcare facilities and clinicians using these devices should immediately discontinue use of recalled lots and contact Abiomed for replacement units. Patients who have received this device should consult with their healthcare provider about the recall.
The recalled product
- Product
- Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device
- Affected units
- 37
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 (3)
- UDI-DI: 00813502013252
- Lot Numbers: 1727033
- 1725590
Distribution
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