Device recall
Z-0660-2016: Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q…
FDA device recall · Class I · St Jude Medical Cardiac Rhythm Management Division
Key facts
| Recall number (Z-number) | Z-0660-2016 |
|---|---|
| Recall event | 72569 |
| Product | Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD). |
| Product code | LWS |
| Recalling firm | St Jude Medical Cardiac Rhythm Management Division |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 10, 2019 |
| PMA numbers | P950022 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database