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Capio RP recallZ-1621-2018 · Boston Scientific Corporation · initiated Feb 12, 2018

Terminated

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 Boston Scientific Corporation 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

Potential for Capio sutures to break and /or detach.

FDA root cause category: Device Design

What the company is doing

Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.

Recall details

Recall number
Z-1621-2018
Status
Terminated
Initiated by the company
Feb 12, 2018
Posted by the FDA
May 4, 2018
Recalling firm
Boston Scientific Corporation
Quantity
2,567
Product code
PWI
Distribution
Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

Product description

Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.

Code information (models, lots, serial numbers)

UDI:08714729470212 Batch numbers:  17813516 18653139 19987270 18014753 18886132 20278129 18015797 19173287 20604455 18015964 19335466 20844362 18234939 19491590 21178815 18237323 19693866 21227473 21386746

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 79608).

Sources and updates

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