Imagertm II Angiographic Catheters
ImagerTM II Angiographic Catheters from all lots are being recalled because they were manufactured with lower-than-approved levels of stabilizing agents in the tips, which could increase the risk of the tip degrading or detaching during use. Although no complaints of tip detachment have been reported so far, the devices do not meet the approved manufacturing specifications. The recall affects catheters distributed to hospitals, pharmacies, and laboratories in New Zealand.
- Recalling firm
- Boston Scientific NZ Ltd
- Product
- ImagerTM II Angiographic Catheters. [Device]. Model: Multiple package codes. Affected: All lots
- Reason
- The manufacturer has determined that these Catheters were manufactured with reduced levels of stabilizing agents in the tips. This may increase the risk of tip degradation and detachment., Although no increase in tip detachment complaints has been identified for the affected lots, the devices were manufactured outside the approved design specification and are being removed from the market.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-20
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/b74c44fb-43dd-46b3-95be-f123b034f9d1