FDA Device recall Z-1099-2018
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are de…
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are de… by Boston Scientific, citing certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1099-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-12 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Identifiers
| code_info | Expiration Date Range: 2/28/2018 - 6/30/2020; Batch: 17885402 19389759 20484324 18312368 19423001 20602275 18795228 1…Expiration Date Range: 2/28/2018 - 6/30/2020; Batch: 17885402 19389759 20484324 18312368 19423001 20602275 18795228 19652457 20346010 19009720 19682505 20484324 19104130 19910674 20602275 19247419 20346010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1099-2018%22
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