Malecot Nephrostomy Catheter System — Class II medical device recall Z-1099-2018
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-1099-2018 |
|---|---|
| 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 | 422 |
| UPC / GTIN / UDI-DI | 08714729030980 |
| Lot numbers | 17885402, 18312368, 18795228, 19009720, 19104130, 19247419, 19389759, 19423001, 19652457, 19682505, 19910674, 20346010, 20484324, 20602275 |
Product
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also designed for internal drainage from the ureteropelvic junction to the bladder.
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-1099-2018. 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.