DLP® 61000 (UDI 20613994846604)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K852232); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 22, 2017Terminated

   Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

   Z-2768-2017 · Root cause: Packaging process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K852232. One submission often covers many models, so check the product and lot details in each record.

• Z-0079-2012 · Sep 9, 2011 · Terminated
  Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyro
• Z-0077-2012 · Sep 9, 2011 · Terminated
  Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg
• Z-0078-2012 · Sep 9, 2011 · Terminated
  Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acryl