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 .
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, 18345738, 18346540, 18346668, 18347522, 18352159, 18354329, 18379847, 18380498, 18393785, 18394034, 18395315, 18408497, 18408902, 18410018, 18428314, 18435809, 18437015, 18437680, 18439474, 18440388, 18444811, 18445630, 18446236, 18462103, 18462459, 18463154, 18466449, 18478544. Model 8106, Lots: 18286550, 18410783. Model 8107, Lots: 18285401, 18285605, 18312411, 18312981, 18313754, 18337534, 18338037, 18354248, 18411116, 18413022, 18413155, 18413834. Model 8108, Lots: 18273724, 18284294, 18338159, 18414856. Model 8109, Lots: 18285220, 18293137, 18294062, 18313856, 18314250, 18332118, 18337848, 18353117, 18415202, 18415923, 18416945, 18418278, 18419899. Model 8110, Lots: 18421013, 18473202. Model 8111, Lots: 18285930, 18351033, 18353540, 18420652, 18468909 . Model 8112, Lots: 18291473, 18336768, 18355225, 18421690, 18427953. Model 8113, Lots: 18324876, 18324963, 18332278, 18352696, 18358192, 18371973, 18372577, 18440783, 18441697, 18467134, 18468171, 18471598, 18472178, 18478892, 18479477. Model 8114, Lots: 18282143, 18284604, 18335173, 18345117, 18441212, 18442550, 18442887. Model 8115, Lots: 18288704, 18328790, 18329233, 18356691, 18357371, 18357372, 18372837, 18373201, 18377504, 18378867, 18446665, 18447045, 18451382, 18451950, 18452785, 18453099, 18464410, 18473932, 18477470, 18483223, 18483940. Model 8116, Lots: 18281865, 18473055. Model 8117, Lots: 18333920, 18334332, 18466601. Model 8118, Lots: 18316161, 18336837, 18348081. Model 8119, Lots: 18286265, 18291252, 18332911, 18336838, 18347898, 18480844, 18483020, 18471580.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- Potential for separation of the proximal handle from the shaft.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 .
Product Codes/Lot Numbers:
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, 18345738, 18346540, 18346668, 18347522, 18352159, 18354329, 18379847, 18380498, 18393785, 18394034, 18395315, 18408497, 18408902, 18410018, 18428314, 18435809, 18437015, 18437680, 18439474, 18440388, 18444811, 18445630, 18446236, 18462103, 18462459, 18463154, 18466449, 18478544. Model 8106, Lots: 18286550, 18410783. Model 8107, Lots: 18285401, 18285605, 18312411, 18312981, 18313754, 18337534, 18338037, 18354248, 18411116, 18413022, 18413155, 18413834. Model 8108, Lots: 18273724, 18284294, 18338159, 18414856. Model 8109, Lots: 18285220, 18293137, 18294062, 18313856, 18314250, 18332118, 18337848, 18353117, 18415202, 18415923, 18416945, 18418278, 18419899. Model 8110, Lots: 18421013, 18473202. Model 8111, Lots: 18285930, 18351033, 18353540, 18420652, 18468909 . Model 8112, Lots: 18291473, 18336768, 18355225, 18421690, 18427953. Model 8113, Lots: 18324876, 18324963, 18332278, 18352696, 18358192, 18371973, 18372577, 18440783, 18441697, 18467134, 18468171, 18471598, 18472178, 18478892, 18479477. Model 8114, Lots: 18282143, 18284604, 18335173, 18345117, 18441212, 18442550, 18442887. Model 8115, Lots: 18288704, 18328790, 18329233, 18356691, 18357371, 18357372, 18372837, 18373201, 18377504, 18378867, 18446665, 18447045, 18451382, 18451950, 18452785, 18453099, 18464410, 18473932, 18477470, 18483223, 18483940. Model 8116, Lots: 18281865, 18473055. Model 8117, Lots: 18333920, 18334332, 18466601. Model 8118, Lots: 18316161, 18336837, 18348081. Model 8119, Lots: 18286265, 18291252, 18332911, 18336838, 18347898, 18480844, 18483020, 18471580.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0588-2016
Related Recalls
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Boston Scientific
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
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 advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia