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CoreTherm
Prostalund AB · Model Penis Safety Probe · UDI-DI 07350081910044
0
510(k) clearances
1,248
Adverse events (7 deaths)
9
Recalls
8
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-04-28 | Urologix, Inc. | Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a mic |
| 2010-02-18 | Urologix, Inc. | Urolgix is recalling certain lots of CTC Advance" catheters and RTU Plus devices which are integral components of the Targis System. The reason for this Recall is a labeling error |
| 2009-07-20 | Boston Scientific Corporation | Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence betwee |
| 2007-03-16 | Urologix, Inc. | The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing. |
| 2007-03-16 | Urologix, Inc. | The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing. |
| 2006-05-04 | Celsion Corporation | A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may fail to achieve or m |
| 2006-03-22 | Celsion Corporation, Inc. | Surgical treatment kits containing medical device components were mislabeled with extended expiration dates. |
| 2004-07-19 | Celsion Corporation | Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient. |
| 2003-12-10 | Urologix, Inc. | During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and may briefly delay up |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.