PlainRecalls
FDA Devices Moderate Class II Terminated

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 cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jack

Reported: January 13, 2016 Initiated: November 25, 2015 #Z-0588-2016

Product Description

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 cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .

Reason for Recall

Potential for separation of the proximal handle from the shaft.

Details

Units Affected
900 units
Distribution
Worldwide Distribution - US (nationwide) and Internationally to 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.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled? ▼
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 cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .. Recalled by Boston Scientific Corporation. Units affected: 900 units.
Why was this product recalled? ▼
Potential for separation of the proximal handle from the shaft.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2016. Severity: Moderate. Recall number: Z-0588-2016.

Related Recalls

FDA Devices Moderate

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Fujirebio Diagnostics, Inc. · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →