FDA Medical Device Recalls (openFDA)
Medtronic Cardiovascular Revascularization & Surgical Therap: DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
- Recall number
- Z-0609-2009
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- Product
- DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
- Status
- Terminated
- Initiated
- 2008-09-29
- Posted
- 2009-01-26
- Terminated
- 2011-05-07
- Reason
- Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were sent a "Medtronic Urgent Medical Device Recall Notice" dated October 1, 2008. The letter described the product and issue. It also requested its customers to return the product and to complete, sign and fax the Recall Certificate "Medtronic Recall Certificate (FCA 0902)". For further information, please contact Medtronic Cardiovascular Revascularization & Surgical Therap by telephone at 763-391-9000.
- Quantity
- 380 US ; 180 OUS
- Distribution
- Worldwide Distribution --- including states of NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland.
- Lot, serial or model codes
- Lot number 2006100305
- 510(k) numbers
- ["K850385"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28