FDA Device recall Z-1101-2018
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to est…
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to est… 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-1101-2018 |
| 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 Set, Product Number: M0064101010, GTIN: 08714729005278 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
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Identifiers
| code_info | Expiration Date Range: 1/22/2018 - 10/4/2021; Batch: 16682347 18705536 20623819 16893775 18773341 20658861 16943409 1…Expiration Date Range: 1/22/2018 - 10/4/2021; Batch: 16682347 18705536 20623819 16893775 18773341 20658861 16943409 18876327 20685659 17003572 18898595 20735791 17017122 18987890 20798226 17075064 19058167 20830240 17184857 19515680 20884480 17192710 19900108 20909296 17603504 20094213 20942365 17703884 20261038 21055683 17797369 20312726 21129580 17990644 20401204 21157953 18084498 20458382 21179391 18095911 20491743 21218849 18691891 20517726 |
|---|
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-1101-2018%22
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