The Recall Desk
ModerateFDA (Devices)·Z-1571-2020·Announced 2020-04-01

Bard PowerPort M.R.I. Implantable Port Catheter Recall for Incorrect Tunneler Tip

Bard Peripheral Vascular Inc is recalling 878 PowerPort M.R.I. Implantable Port catheters because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The identified hazard is a manufacturing error that results in a prolongation of the operation, which is a procedural inconvenience rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 878 units of PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter. The recall involves three specific product references: 1809600, 1809601, and 1859600. These devices are indicated for patient therapies requiring repeated access to the vascular system, including the infusion of medications, I.V. fluids, parenteral nutrition solutions, and blood products.

The firm identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This manufacturing error can result in a prolongation of the surgical operation. The affected lots are 1809600 (RECR1434, RECT0091), 1809601 (RECT0189), and 1859600 (RECR2072, RECS1118).

The products were distributed worldwide, including nationwide distribution in the United States and in countries such as Brazil, Canada, EMEA, Korea, Mexico, and New Zealand. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact Bard Peripheral Vascular Inc for further instructions on handling the recalled devices.

The recalled product

Product
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs,
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Implantable Port
Hazard
Affected units
878

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 1. Lot #s 1809600- RECR1434
  • RECT0091 2. Lot #s 1809601- RECT0189
  • 3. Lot #s 1859600- RECR2072
  • RECS1118

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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