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Boston Scientific Corporation alerts
Verified recalls, refunds, lawsuits, and settlements involving Boston Scientific Corporation.
Recall
Active
FDA
Official source
Potential for breach in sterile barrier of device packaging. Product details: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5;...
- Company
- Boston Scientific Corporation
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration
Recall
Active
FDA
Official source
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation...
- Company
- Boston Scientific Corporation
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration
Recall
Active
FDA
Official source
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. Product details: FARASTAR...
- Company
- Boston Scientific Corporation
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration
Recall
Active
FDA
Official source
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. Product details: FARASTAR Pulsed Field Ablation Generator,...
- Company
- Boston Scientific Corporation
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration
Recall
Active
FDA
Official source
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose...
- Company
- Boston Scientific Corporation
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration
Recall
Active
FDA
Official source
Potential sterile breach of the pouches in which devices are packaged. Product details: CRE Pro Wireguided 12-15mm 240cm
- Company
- Boston Scientific Corporation
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration
Recall
Active
FDA
Official source
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the...
- Company
- Boston Scientific Corporation
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration