FDA Device recall Z-1104-2018
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish pe…
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish pe… 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-1104-2018 |
| 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
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
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Identifiers
| code_info | Expiration Date Range: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232…Expiration Date Range: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232 18071028 19272679 16687725 18187908 19323232 16701905 18238926 19338380 16725748 18312539 19374391 16746021 18347202 19419431 16768170 18403711 19510783 16769687 18453529 19543444 16791047 18467224 19596296 16813326 18511816 19622910 16861185 18522401 19652445 16886796 18631119 19672586 16911889 18702248 19824542 16918770 18702249 19884752 16931022 18705836 20001153 16931071 18780195 20091268 16964525 18800088 20118753 17143046 18818625 20198261 17227380 18820391 20288613 17399143 18900337 20321757 17446684 18900338 20477761 17604237 18955686 20753764 17659535 18977772 20789373 17670349 19006930 21009191 17710577 19087159 21046808 17766030 19097822 21316321 17826778 |
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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-1104-2018%22
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