| Date Initiated by Firm | April 29, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on April 21, 2006 |
| Recall Number | Z-0944-04 |
|---|
| Recall Event ID |
28982 |
| Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
|
| Product | Deikos A+ |
|---|
| Code Information |
Model Number 334 341 Serial numbers: 78062958, 78062960, 78062961, 78062962, 78062997, 78063002 |
Recalling Firm/
Manufacturer |
Biotronik Inc
6024 Jean Rd
Lake Oswego OR 97035-5308
|
| For Additional Information Contact | Jon Brumbaugh
888-345-0374 |
|---|
Manufacturer Reason
for Recall | Potential for device to not deliver full amount of energy |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated. |
|---|
| Quantity in Commerce | 6 |
|---|
| Distribution | Devices were distributed to physicians and medical centers throughout the U.S.
The firm does not distribute internationally. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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