Cre Balloon Dilatation Catheter Family
Boston Scientific Corporation is recalling the CRE Balloon Dilatation Catheter family of medical devices distributed to hospitals, pharmacies, and laboratories in New Zealand. The company has requested that these products be returned to the supplier. This is classified as a Class I recall, which is the most serious type of recall.
- Recalling firm
- Boston Scientific NZ Ltd
- Product
- CRE Balloon Dilatation Catheter family. [Device]. Model: CRETM Wireguided and CRE PROTM Balloon Dilation Catheters. Affected: Multiple lots
- Reason
- The manufacturer is initiating removal of CRE Wireguided and CRE PRO Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract. The reported problem is highly detectable upon visual inspection of the silver side of the pouch. aints received to date, none have, been reported within Australia. The most common adverse health consequence reasonably foreseeable to occur is a prolonged, procedure of negligible severity to account...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-05-21
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/ae0b0997-814d-4e54-bd33-0ef5cc80e0dc