FDA Device recall Z-1731-2020
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
- FDA Device
- Class II
- ongoing
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit by Boston Scientific, citing an increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1731-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-03-09 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Reason
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Identifiers
| code_info | Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 245…Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 24577900, 24579133, 24580102, 24583255, 24585905, 24586401, 24616721, 24617337, 24618334, 24724936, 24732742, 24737184, 24739802, 24790717, 24805720, 24860825, 24868932 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1731-2020%22
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