FARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
Boston Scientific recalls cardiac ablation generators due to incomplete Instructions For Use that omit information about a compatible catheter.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a documentation issue classified as a labeling discrepancy where the Instructions For Use are missing information about a compatible catheter. Per the rubric, documentation issues are classified as Low severity.
Plain-English summary
Boston Scientific Corporation is recalling its FARASTAR Pulsed Field Ablation Generator (Product ID M004PFCE61M401) and Percutaneous Cardiac Ablation Catheter. The recall is being issued due to a labeling discrepancy where the Instructions For Use (IFU) distributed with the devices did not include information about the FARAPOINT PFA catheter.
The affected devices were internationally distributed in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. The specific product can be identified by GTIN 00191506042547 and serial number 106247020.
Patients and healthcare providers should discontinue use of the affected devices and contact Boston Scientific Corporation for replacement documentation and further instructions. No injuries or illnesses have been reported in connection with this labeling issue.
The recalled product
- Product
- FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1
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 (2)
- GTIN 00191506042547
- Serial Numbers: 106247020.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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