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Medtronic SiteSeer 5 F Tight Radius 145 Pigtail recallZ-0523-04 · Medtronic, Inc. · initiated Jan 14, 2004

Terminated All recalls posted in February 2004

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Catheter distal tip may separate

FDA root cause category: Other

What the company is doing

Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.

Recall details

Recall number
Z-0523-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 14, 2004
Posted by the FDA
Feb 10, 2004
Recalling firm
Medtronic, Inc.
Quantity
20 units
Product code
DQO
FDA submissions
K932092
Distribution
NC, WA

Product description

Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029

Code information (models, lots, serial numbers)

Lot Number: 160760 Expiration Date: 2006-12

Other devices under the same FDA submission

2 devices cleared under K932092 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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