Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter Recall for Handle Separation
Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving structural defects in medical devices are assigned a severity score of 4 (Severe).
Plain-English summary
Boston Scientific Corporation is recalling 900 units of the ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. The affected models include 8104 through 8119, with specific lot numbers listed in the agency documentation. The product is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature.
The recall is being conducted because of a potential for separation of the proximal handle from the shaft. This defect could compromise the integrity of the catheter during use. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Argentina, Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, and Thailand. Healthcare providers should stop using the affected devices and contact Boston Scientific for further instructions.
The recalled product
- Product
- Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of ca
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 900
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 (20)
- Model 8104
- Lots: 18279548
- 18279734
- 18324877
- 18329863
- 18330946
- 18348755
- 18351569
- 18353214
- 18426640
- 18461104
- 18461521. Model 8105
- Lots: 18281110
- 18315176
- 18322343
- 18323156
- 18323651
- 18324468
- 18327210
- 18327359
Distribution
Distributed nationwide across the United States.
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