Percutaneous Access Set — Class II medical device recall Z-1104-2018
Terminated recall by Boston Scientific Corporation, reported 2018-03-28, distributed nationwide. Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
| Recall number | Z-1104-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2017-12-12 |
| Classified | 2018-03-18 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BO, BR, CA, CL, CN, CR, DO, EC, GT, KR, KW, LB, MX, MY, PA, PE, PH, SA, SG, SV, TR, VE, ZA |
| Quantity | 3,762 |
| UPC / GTIN / UDI-DI | 08714729009757 |
| Lot numbers | 16602757, 16632804, 16668232, 16687725, 16701905, 16725748, 16746021, 16768170, 16769687, 16791047, 16813326, 16861185, 16886796, 16911889, 16918770, 16931022, 16931071, 16964525, 17143046, 17227380, 17399143, 17446684, 17604237, 17659535, 17670349, 17710577, 17766030, 17826778, 17989189, 18000051, 18071028, 18187908, 18238926, 18312539, 18347202, 18403711, 18453529, 18467224, 18511816, 18522401 and 42 more |
Product
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
Reason for recall
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
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-1104-2018. 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.