Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter — Class II medical device recall Z-0588-2016
Terminated recall by Boston Scientific Corporation, reported 2016-01-13, distributed nationwide. Potential for separation of the proximal handle from the shaft.
| Recall number | Z-0588-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2015-11-25 |
| Classified | 2016-01-05 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CH, CO, CY, CZ, DE, EG, ES, FI, FR, GB, GR, HK, IE, IT, JP, MY, NL, PL, PT, RS, SE, SG, SI, TH |
| Quantity | 900 units |
| Lot numbers | 18273724, 18279548, 18279734, 18281110, 18281865, 18282143, 18284294, 18284604, 18285220, 18285401, 18285605, 18285930, 18286265, 18286550, 18288704, 18291252, 18291473, 18293137, 18294062, 18312411, 18312981, 18313754, 18313856, 18314250, 18315176, 18316161, 18322343, 18323156, 18323651, 18324468, 18324876, 18324877, 18324963, 18327210, 18327359, 18328790, 18329233, 18329863, 18330946, 18332118 and 109 more |
| Model numbers | 18273724, 18279548, 18279734, 18281110, 18281865, 18282143, 18284294, 18284604, 18285220, 18285401, 18285605, 18285930, 18286265, 18286550, 18288704, 18291252, 18291473, 18293137, 18294062, 18312411, 18312981, 18313754, 18313856, 18314250, 18315176 and 140 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0588-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.