Agency classClass IIOur severity:Severe FDA (Devices)·Z-0588-2016·Announced 2016-01-13

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cardiac Catheter
Hazard: structural-defect
component-separation
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.

Same manufacturer · Boston Scientific Corporation

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